Stroke, AcuteEASYNCT02216565
Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase
A study testing Hospitalization in specialized neuro-vascular unit, Alteplase if patient is eligible and Supportive care in people with Stroke, Acute, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
Trial summary
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. Read more about this study
- Who is it for?
- Ages 18 to 82 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Hospitalization in specialized neuro-vascular unit, Alteplase if patient is eligible and Supportive care
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2014to 24 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologically proven acute proximal occlusion of middle cerebral artery
- AND one of the three following :
- tandem internal carotid / middle cerebral artery occlusion
- intravenous thrombolysis contraindicated because of high risk of haemorrhage
- intravenous thrombolysis not possible because of delay > 4.5 hours
Who cannot join
- Impossibility to perform endovascular recanalization within 6h
- Clinically minor stroke (NIHSS score below 5 at baseline)
- Extended cerebral infarction
- Severe comorbidity
- Life expectancy below 3 months before stroke
- Pregnancy or breastfeeding
- modified Rankin Score superior to 2 before stroke
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Henri Mondor
Créteil, 94010
Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
Hopital Foch
Suresnes, 92151
About this study
Official title: Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.
The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.
The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone
- Conditions
- Stroke, Acute
- Being tested
- Hospitalization in specialized neuro-vascular unit, Alteplase if patient is eligible, Supportive care, Endovascular treatment
- Keywords
- Stroke, Endovascular treatment, Tandem carotid occlusions, Fibrinolysis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospitalization in specialized neuro-vascular unitOther
Alteplase if patient is eligibleDrug
Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
Supportive careOther
Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
Endovascular treatmentProcedure or surgery
Recanalization treatment (thrombectomy / intraarterial thrombolysis)
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment | Other | Conventional medical non-interventional treatment Receives: Other: Hospitalization in specialized neuro-vascular unit; Drug: Alteplase if patient is eligible; Other: Supportive care |
| Endovascular treatment | Other | Conventional medical treatment plus endovascular treatment Receives: Other: Hospitalization in specialized neuro-vascular unit; Drug: Alteplase if patient is eligible; Other: Supportive care; Procedure: Endovascular treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in NIHSS score after 24h
Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow :
[NIHSS(t0) - NIHSS(t1)] / NIHSS(t0)
Measured: 24 hours
Secondary outcomes (4)
Improvement in NIHSS score after 7 days
Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and day7 (t2) calculated as follow :
[NIHSS(t0) - NIHSS(t2)] / NIHSS(t0)
Measured: 7 days
Functional recovery after 3 months
modified Rankin Score (mRS) after 3 months ("positive recovery" if mRS <=2, "excellent recovery" if mRS<=1)
Measured: 3 months
Fatality within 7 days
Proportion of patients deceased within seven days after stroke
Measured: 7 days
Fatality within 3 months
Proportion of patients deceased within 3 months after stroke
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start1 Dec 2014
- Primary completion31 Aug 2015
- Study completion24 Aug 2017
Why it stopped: After results of other studies published : EASY study became lapsed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Marc-Antoine Labeyrie, MD, Principal investigator, Hopital Lariboisiere, ParisMichel Piotin, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216565
- Sponsor's protocol ID
- 2014-A00519-38
- Acronym
- EASY
- Status last verified
- Dec 2017
- First submitted
- 13 Aug 2014
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial
- ClinicalTrials.gov ID
- NCT02216565
- Acronym / sponsor ID
- EASY / 2014-A00519-38
- Conditions
- Stroke, Acute
- Keywords
- Stroke, Endovascular treatment, Tandem carotid occlusions, Fibrinolysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After results of other studies published : EASY study became lapsed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 24 Aug 2017 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.
The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.
The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical treatment | Other | Other: Hospitalization in specialized neuro-vascular unit, Drug: Alteplase if patient is eligible, Other: Supportive careConventional medical non-interventional treatment |
| Endovascular treatment | Other | Other: Hospitalization in specialized neuro-vascular unit, Drug: Alteplase if patient is eligible, Other: Supportive care, Procedure: Endovascular treatmentConventional medical treatment plus endovascular treatment |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Radiologically proven acute proximal occlusion of middle cerebral artery
- tandem internal carotid / middle cerebral artery occlusion
- intravenous thrombolysis contraindicated because of high risk of haemorrhage
- intravenous thrombolysis not possible because of delay > 4.5 hours
Key exclusion criteria (7 listed)
- Impossibility to perform endovascular recanalization within 6h
- Clinically minor stroke (NIHSS score below 5 at baseline)
- Extended cerebral infarction
- Severe comorbidity
- Life expectancy below 3 months before stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospitalization in specialized neuro-vascular unit | Other | Endovascular treatment, Medical treatment |
| Alteplase if patient is eligibleAlteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated) | Drug | Endovascular treatment, Medical treatment |
| Supportive careDrugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition | Other | Endovascular treatment, Medical treatment |
| Endovascular treatmentRecanalization treatment (thrombectomy / intraarterial thrombolysis) | Procedure or surgery | Endovascular treatment |
Primary outcome
Improvement in NIHSS score after 24h
Time frame: 24 hours
Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow : [NIHSS(t0) - NIHSS(t1)] / NIHSS(t0)
4 secondary outcomes
Improvement in NIHSS score after 7 days
Time frame: 7 days
Functional recovery after 3 months
Time frame: 3 months
Fatality within 7 days
Time frame: 7 days
Fatality within 3 months
Time frame: 3 months
Results and safety
The study was stopped early (reason given: After results of other studies published : EASY study became lapsed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-Antoine Labeyrie, MD principal investigator
Hopital Lariboisiere, Paris
Michel Piotin, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild, Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospitalization in specialized neuro-vascular unit, Alteplase if patient is eligible and Supportive care in people with Stroke, Acute, run by Fondation Ophtalmologique Adolphe de Rothschild at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: After results of other studies published : EASY study became lapsed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in NIHSS score after 24h (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.